创新药研发与审评过程中的沟通交流  

The communication during innovative drug research and development and review

作　　者：杨建红[1] 史继峰[1] 温宝书[1] 何燕萍[1] 冯毅[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2010年第19期1744-1746,1802,共4页Chinese Journal of New Drugs

摘　　要：沟通交流是药品注册申请人与药品评价机构在药物研发的里程碑阶段就特定阶段的重大决策、重要科学问题、关键技术问题等进行讨论,在此基础上形成继续推进研究、中止研究、暂停研究等决策建议。文中对我国创新药沟通交流的开展情况、存在问题进行了归纳分析,以期对国内创新药研发者有所帮助。During key stages of drug research and development,the communication between drug applicants and Center for Drug Evaluation is to discuss major decision makings,important scientific issues and key technical problems in specific stages.This could help applicants to decide whether to promote,discontinue or suspend the research.In this article,we generalized and analyzed the situations and problems of communications on innovative drug research and development,expecting to benefit domestic innovative drug researchers.

关 键 词：创新药 研发 审评 沟通交流 

分 类 号：R95[医药卫生—药学]